设施
工厂面积：20,000平方英尺
每日废水处理量：50吨
设施：盐水冷冻、压缩空气、去离子水等装置
蒸汽：工业园集中提供
Non-GMP公斤级实验室：17个反应釜（50-100L）
cGMP公斤级实验室：5个反应釜（100-200L）
Non-GMP中试工厂：20个反应釜（300-5000L）
我们的优势
健全的质量管理体系
桑迪亚的质量保证部门已经建立了一套符合中、美FDA cGMP质量体系，从原材料到产品，实验室到中试工厂，操作工到首席执行官，我们都建立了近百条标准操作规程以确保我们提供的服务和产品的质量。我们的员工在每次独立完成客户项目之前都会在包括操作、安全性、数据完整性、保密性等各方面经过严格培训合格后参与工作。桑迪亚已经成功通过了数百个来自全球制药公司和药监局的审计以及现场核查
质量保证
我们建立了标准的操作规程、培训管理、良好的文档实践、存档管理、材料管理、规范管理、供应商资质和合同制造商资质，校准、维护，质量意外管理包括服务偏差、服务中断、客户投诉、产品召回以及变更控制、验证和资质管理、包装和标签管理、内部审计和例行检查
完善的EHS体系
EHS方针
严格遵守所有适用的国家法律、法规和标准
建立并实施良好的公司内部的各项EHS制度与管理程序
EHS职责
EHS部门负责提供安全指导，对所有危险反应进行专业培训，负责作业现场的安全，负责常规安全评估报告以及其他安全相关事务
可持续发展目标
严格控制废气废液排放，提高废弃物处理能力以尽量减少对环境的影响
我们的优势
通过多家国际大型制药公司EHS, GMP查核：
| Clients | Indications | Sundia Support | ||
|---|---|---|---|---|
| Amount | Status | Description | ||
| US | Rare Disease | 2kg (2013) , 8 kg (2014) | Phase III | Providing GMP starting material |
| US | Oncology | 15kg (2013~2014) 20kg (2015~2016) |
Phase II/III | API production |
| US | Oncology | 5kg (2015~2016) | PCD | API production |
| US | Oncology | 150kg (2015~2016) | PCD | Providing GMP starting material |
| Canada | Breast cancer | 30kg (2015~2016) | Phase I | API production |
| Korea | Inflammatory disease | 4kg (2014), 10kg (2015~2016) | Phase II | API production |
| Korea | Oncology | 20kg (2015~2016) | PCD | Providing GMP starting material |
| Korea | Antibiotics | 5 kg (2014) | PCD | Providing GMP starting material |
| Korea | Lung cancer | 1500kg (2013~2014) 1500kg (2015~2016) |
Phase III | Providing GMP starting material |
| EU | Chemotherapy-induced Neuropathic Pain | 1 kg (2015) | Phase I | API process develop |
| 7 kg (2015) | Providing GMP starting material | |||
| Australia | N/A | 10kg (2015~2016) | PCD | API/GMP starting material |
| EU | Rare Disease | 100kg (2015~2016) | Phase III | Providing GMP starting material |
| UK | N/A | 100kg (2015) 200kg (2016) |
Phase I | Provide Material for GMP production |
| China | Anti-HIV | 20kg (2015~2016) | Phase I | API production |
| China | Oncology | 30kg (2016) | Phase I | Providing GMP starting material |
| China | Oncology | 100kg (2015~2016) | PCD | Providing GMP starting material |
| China | Antilipemic | 10kg (2015~2016) | Phase I | API production |
| China | Lung cancer | 5kg (2014) 10kg (2015~2016) |
Phase I | API production |
| China | Oncology | 5kg (2015) | Phase I | API production |
| Taiwan | Periodic Paralysis | 2kg (2015) | PCD | API production |
| Japan | N/A | 100kg(2015), 500kg (2016) | N/A | Provide Material for GMP production |
| Japan | N/A | 1kg (2015), 40kg (2016) | N/A | Provide Material for GMP production |
IND中报项目:
| Classification | Pharmacology | Indications |
|---|---|---|
| Chemical Drug 1.1 | RR inhibitor | Cancer |
| Chemical Drug 1.1 | Multi targeted RTK inhibitor | Cancer |
| Macular degeneration | ||
| Herbal Medicine 5 | Non hormones | Endometriosis |
| Chemical Drug 1.5 | Prescription | Common cold |
| Chemical Drug 1.1 | NP inhibitor | Cancer |
| Chemical Drug 1.1 | Neuroprotectant | Stroke |
| Chemical Drug 1.1 | ALK/MET inhibitor | Cancer |
| Chemical Drug 1.1 | LDLR regulator | Hyperlipoidemia |
| Chemical Drug 1.1 | Multi targeted RTK inhibitor | Cancer |
| Chemical Drug 1.1 | b-RAF inhibitor | Cancer |
| Chemical Drug 1.1 | Protease inhibitor | Cancer |
| Chemical Drug 1.1 | mTOR inhibitor | Cancer |
| Chemical Drug 1.1 | NS3-4A Protease inhibitor | HCV |
| Chemical Drug 1.1 | Multi targeted RTK inhibitor | Cancer |
| Chemical Drug 1.1 | MEK inhibitor | Cancer |
| Chemical Drug 1.1 | Pro drug | Leukemia |
| Chemical Drug 1.1 | Multi targeted drug | Senile dementia |
| Chemical Drug 1.1 | PARP inhibitor | Cancer |
| Chemical Drug 1.1 | Peptide Pro drug | Cancer |
| Chemical Drug 1.1 | Confidential | Diabetes |
| Chemical Drug 1.1 | Confidential | Cancer |
| Chemical Drug 1.1 | Antivirus | Confidential |
| Chemical Drug 1.1 | Confidential | Cancer |
